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Biotech / Medical : Provectus Pharmaceuticals Inc.
PVCT 0.06490.0%9:51 AM EST
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Rutgers
To: pincus who wrote (12130)6/28/2013 6:13:21 PM
From: boomertree21 Recommendation   of 13111
 
There have been no delays caused by the FDA reorganization. The FDA reorganization had its intended affect of expediting approvals, and the recent record of FDA approvals bears this out.....see my email below from a couple weeks ago.

New Melanoma Treatments Bring FDA Approval Tally To 13. Reuters (5/31, Hirschler, Berkrot) reports that the US Food and Drug Administration’s statement Wednesday announcing it approved two of GlaxoSmithKline’s new oral treatments for metastatic or unresectable melanoma – Tafinlar (dabrafenib) and Mekinist (trametinib) – brings the total number of new drugs approved this year to 13, whereas around the same time last year, the agency had approved 11 new medications. Overall in 2012, the FDA approved 39 new treatments, representing the most drug products cleared by the agency since 1996.

FDA moving more quickly on new drug approvals, but PVCT management can't get a phase III protocol approved 3 years after end of phase II trials. Management exceptional......yes, exceptionally bad. The only material change since the end of the phase II trial is that we now have less money to fund the phase III trial since management has been paying itself millions every year for no measurable progress.
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